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EP4302754A4 - Composition de nanoparticules d'albumine et de docétaxel stable - Google Patents

Composition de nanoparticules d'albumine et de docétaxel stable Download PDF

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Publication number
EP4302754A4
EP4302754A4 EP22762626.4A EP22762626A EP4302754A4 EP 4302754 A4 EP4302754 A4 EP 4302754A4 EP 22762626 A EP22762626 A EP 22762626A EP 4302754 A4 EP4302754 A4 EP 4302754A4
Authority
EP
European Patent Office
Prior art keywords
nanoparticle composition
albumin nanoparticle
docetaxel albumin
stable
stable docetaxel
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22762626.4A
Other languages
German (de)
English (en)
Other versions
EP4302754A1 (fr
Inventor
Chunlei Li
Xiaojun Zhang
Yuanyuan Zhao
Dongjian CHEN
Min Liang
Qianbin XING
Nan Li
Yun SHU
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co Ltd
Original Assignee
CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co Ltd filed Critical CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co Ltd
Publication of EP4302754A1 publication Critical patent/EP4302754A1/fr
Publication of EP4302754A4 publication Critical patent/EP4302754A4/fr
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51Nanocapsules; Nanoparticles
    • A61K9/5107Excipients; Inactive ingredients
    • A61K9/513Organic macromolecular compounds; Dendrimers
    • A61K9/5169Proteins, e.g. albumin, gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dispersion Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Optics & Photonics (AREA)
  • Nanotechnology (AREA)
  • Biomedical Technology (AREA)
  • Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EP22762626.4A 2021-03-05 2022-03-04 Composition de nanoparticules d'albumine et de docétaxel stable Pending EP4302754A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202110243298 2021-03-05
PCT/CN2022/079286 WO2022184164A1 (fr) 2021-03-05 2022-03-04 Composition de nanoparticules d'albumine et de docétaxel stable

Publications (2)

Publication Number Publication Date
EP4302754A1 EP4302754A1 (fr) 2024-01-10
EP4302754A4 true EP4302754A4 (fr) 2024-12-18

Family

ID=83119428

Family Applications (1)

Application Number Title Priority Date Filing Date
EP22762626.4A Pending EP4302754A4 (fr) 2021-03-05 2022-03-04 Composition de nanoparticules d'albumine et de docétaxel stable

Country Status (8)

Country Link
US (1) US20240156774A1 (fr)
EP (1) EP4302754A4 (fr)
JP (1) JP2024510156A (fr)
KR (1) KR20230154864A (fr)
CN (2) CN115025053B (fr)
AU (1) AU2022230634A1 (fr)
CA (1) CA3212544A1 (fr)
WO (1) WO2022184164A1 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3166973A1 (fr) * 2020-02-04 2021-08-12 Qun Sun Formulations de docetaxel
CN115957197B (zh) * 2022-12-22 2024-03-01 沈阳药科大学 包载抗炎药物的西维来司他偶联ros敏感白蛋白纳米粒及其制备方法和应用
WO2024230772A1 (fr) * 2023-05-09 2024-11-14 江苏康宁杰瑞生物制药有限公司 Médicament de polythérapie comprenant un anticorps bispécifique anti-her2 et son utilisation

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101361731A (zh) * 2008-08-11 2009-02-11 张文芳 白蛋白稳定的多西紫杉醇冻干制剂及其在治疗肿瘤方面的应用
CN102688200A (zh) * 2012-05-09 2012-09-26 刘锋 植物类抗癌靶向纳米制剂及其制备方法
CN103202812B (zh) * 2010-08-09 2015-10-28 南京大学 一种制备用于体内递送药理活性物质的蛋白纳米粒的方法
US20200061020A1 (en) * 2017-05-01 2020-02-27 Zhuhai Beihai Biotech Co., Ltd. Formulations and compositions of docetaxel

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000006152A1 (fr) * 1998-07-30 2000-02-10 Novopharm Biotech, Inc. Composition pharmaceutiquement acceptable comprenant une solution aqueuse de paclitaxel et d'albumine
ITMI20020680A1 (it) * 2002-03-29 2003-09-29 Acs Dobfar Spa Composizione antitumorale migliorata a base di paclitaxel e metodo per il suo ottenimento
CN1448132A (zh) * 2002-03-29 2003-10-15 艾斯·多伯法股份公司 改进的基于紫杉醇的抗肿瘤制剂
CN103405405A (zh) 2002-12-09 2013-11-27 阿布拉西斯生物科学有限责任公司 组合物和传递药剂的方法
WO2007027941A2 (fr) * 2005-08-31 2007-03-08 Abraxis Bioscience, Llc. Compositions et methode de preparation de medicaments a faible solubilite dans l'eau presentant une stabilite accrue
LT1931321T (lt) 2005-08-31 2019-05-10 Abraxis Bioscience, Llc Kompozicijos, apimančios silpnai vandenyje tirpius farmacinius agentus ir antimikrobinius agentus
CN102988996A (zh) * 2012-12-19 2013-03-27 清华大学 一种制备稳定的白蛋白纳米颗粒的方法
WO2015018380A2 (fr) * 2014-07-03 2015-02-12 Cspc Zhongqi Pharmaceutical Technology(Shijiazhuang)Co., Ltd. Nanoparticules thérapeutiques et leurs procédés de préparation
CN106137969B (zh) 2015-04-03 2020-05-15 四川科伦药物研究院有限公司 多西他赛白蛋白纳米粒药物组合物及其制备方法及应用
US11154511B2 (en) 2016-09-29 2021-10-26 Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. Albumin pharmaceutical composition and preparation method therefor
CN106333941B (zh) * 2016-10-24 2019-12-13 聊城大学 一种紫杉醇白蛋白复合物的制备工艺
CN106420665B (zh) * 2016-10-28 2019-04-16 浙江省林业科学研究院 一种包裹紫杉烷类药物的白蛋白纳米颗粒载体的制备方法

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101361731A (zh) * 2008-08-11 2009-02-11 张文芳 白蛋白稳定的多西紫杉醇冻干制剂及其在治疗肿瘤方面的应用
CN103202812B (zh) * 2010-08-09 2015-10-28 南京大学 一种制备用于体内递送药理活性物质的蛋白纳米粒的方法
CN102688200A (zh) * 2012-05-09 2012-09-26 刘锋 植物类抗癌靶向纳米制剂及其制备方法
US20200061020A1 (en) * 2017-05-01 2020-02-27 Zhuhai Beihai Biotech Co., Ltd. Formulations and compositions of docetaxel

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2022184164A1 *

Also Published As

Publication number Publication date
US20240156774A1 (en) 2024-05-16
JP2024510156A (ja) 2024-03-06
EP4302754A1 (fr) 2024-01-10
WO2022184164A1 (fr) 2022-09-09
KR20230154864A (ko) 2023-11-09
CA3212544A1 (fr) 2022-09-09
CN115025053B (zh) 2024-08-30
CN115025053A (zh) 2022-09-09
CN118903027A (zh) 2024-11-08
AU2022230634A1 (en) 2023-09-21

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